EC Declaration of Conformity
Date: 2025-08-06
Manufacturer Information
- Manufacturer:
- Beurer GmbH (see address in footer)
- SRN:
- DE-MF-000005422
Product Details
- Product category:
- Medical device software
- Product type:
- Module.MAP
The product specified above is in conformity with the following specifications.
Conformity Specifications
- (EU) 2017/745:
- Medical device regulation (MDR)
- Basic-UDI-DI:
- 4211125Module.MAPQC
- Classification/applied rule(s):
- Class IIa/rule 10 and rule 11
- Conformity assessment procedure:
- Annex IX, Chapter I
Notified Body Information
The notified body mdc medical device certification GmbH, located at Kriegerstr. 6, 70191 Stuttgart, Germany, identification number 0483, issued in the course of the mentioned conformity assessment procedure the following certificate:
- Certificate no. and validity:
- D1311700063, valid to 2026-04-07
Declaration Statement
This declaration of conformity is issued under the sole responsibility of the manufacturer.
- Signed for and on behalf of:
- Beurer GmbH
- Place, date of issue:
- Ulm, 2025-08-06
- Name, function, signature, stamp:
- Werner Metemek, Director Quality Management & Regulatory Affairs
ppa. [signature placeholder]
Beurer GmbH
Söflinger Straße 218 • 89077 Ulm